Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
This workshop will review the current regulations, guidance documents for early stage manufacturing and GMPs in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
So, that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
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Despite US legislation in 2010 that moved the country closer to achieving universal healthcare, costs have continued to rise and nearly 26 million Americans are still uninsured according to the Congressional Budget Office.
As Republicans decide whether to repeal or replace the struggling healthcare policy, how does the existing US healthcare system compare with those in other countries?
Broadly speaking, the World Health Organization (WHO) defines universal health coverage as a system where everyone has access to quality health services and is protected against financial risk incurred while accessing care.
A brief history of the healthcare systems used today
Among the 35 OECD member countries, 32 have now introduced universal healthcare legislation that resembles the WHO criteria.
In Germany, the world’s first national health insurance system shows how UHC often evolves from an initial law. Originally for industrial labourers, cover gradually expanded to cover all job sectors and social groups, with today’s German workers contributing around 15% of their monthly salary, half paid by employers, to public sickness funds.
Established in 1948 to be free at the point of use, the UK’s NHS has almost totemic status for Britain’s rising, ageing population who scrutinise it like perhaps no other policy area. While care from GP services to major surgery remains free as intended, the system is under unprecedented financial strain from a funding gap estimated to be in the billions.
Under France’s state-run equivalent of the UK’s NHS, the majority of patients must pay the doctor or practitioner upfront. The state then reimburses them in part or in full. Workers make compulsory payments into state funds used to reimburse between 70% and 100% of the upfront fees, while many people pay into other schemes to cover the balance.
In the mid-1960s, the United States implemented insurance programs called Medicare and Medicaid for segments of the population including low income and elderly adults. In 2010, Obamacare became the closest the US has come to a system of UHC. A legal mandate now requires all Americans to have insurance or pay a penalty. About 26 million people remain without health insurance despite these advances.
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Spending compared with life expectancy
Life expectancy in the US is still lower than other developed countries, despite health funding increasing at a much faster pace.
How healthcare is funded has a direct effect on the level of healthcare people have access to.
Single-payer
The state funds an agreed range of services through public clinics that are paid for through taxes
For example, in Sweden there is a limit in how much you pay for healthcare in one year of between 900-1100 kronor (£80-£100)
Two-tier
Government healthcare may be less comprehensive and minimum level of coverage can be supplemented by private insurance
In Australia, hospital treatment is covered by Medicare, yet most people pay a fee to see a GP or for ambulance services. 57% of adults have private insurance
Insurance mandate
A two-tier system underpinned by an insurance mandate where citizens are legally required to purchase cover from public or private insurers
Most people in Japan receive health insurance from their employer, otherwise they must sign up for a national health insurance programme. Medical fees are regulated to keep them affordable
How could the US healthcare system change?
Donald Trump ran on a campaign to repeal and replace the Affordable Care Act, popularly known as Obamacare, but discord among Republicans has highlighted the political challenges faced with implementing a healthcare system, much less trying to change it.
With millions still uninsured and the financial burden of healthcare still quite high, the current US policy falls short of the WHO threshold.
Thus far, separate bills introduced in the House and the Senate were estimated to see steep increases in the number of uninsured from current levels.
Estimated uninsured under existing and proposed healthcare plans
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